Change in depression severity measured by the 21-item Hamilton Depression Rating Scale (Baseline versus end of treatment/ day 19)

Change in the Beck Depression Inventar, the Clinical Global Impression Scale, the Global Assessment of Functioning scale, the Alertness (Baseline versus end of treatment/ day 19, follow-up I/ day 47, follow-up II/ day 75)

Number of responders (response = decrease of the Hamilton Depression rating scale for at least 50%) (Baseline versus end of treatment/ day 19, follow-up I/ day 47, follow-up II/ day 75)

61

All

18 Years to 70 Years (Adult, Senior)

NCT01240083

Uni-Reg-TB1

April 2010

September 2011

October 2011

November 15, 2010

October 16, 2013

University of Regensburg- Dept of PsychiatryRegensburg, Bavaria, Germany

The primary outcome measure used is the MADRS (Montgomery-Asberg Depression Rating Scale). At study end response criteria is defined as a 50% reduction in total MADRS score and remission defined as less or equal to 10.